The Food and Drug Administration on Monday approved the Medicines Co.'s blood clot prevention drug Kengreal. The approval comes after a decade and $200 million were spent developing the drug.
The intravenous drug Kengreal can be used in adults undergoing percutaneous coronary interventions, which are performed to open a blocked or narrowed coronary artery.
“The approval of Kengreal provides a new option for PCI,” Dr. Clive Meanwell, chairman and CEO of the Medicines Co., said in a statement. “This novel drug will potentially decrease thrombotic risk in the acute-care setting.”
The FDA rejected the drug over the span of a decade, citing the failure of two clinical trials to prove efficacy for the indications the drugmaker was seeking.
In April, an FDA advisory panel voted 9-2 to recommend approval once the Medicines Co. narrowed the drug's indication for use as an adjunct therapy for patients undergoing PCI, which the Centers for Disease Control and Prevention estimates are performed on about 500,000 Americans a year.
“For patients undergoing percutaneous coronary intervention, blood clotting can cause serious problems,” Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research, said in a statement.
Results from a clinical trial comparing Kengreal to Plavix in more than 10,000 patients showed Kengreal reduced occurrence of heart attack and stent thrombosis over the Bristol-Meyers Squibb drug. The trial found that the chances for serious bleeding was low in both drugs, but was elevated in Kengreal.
According to the FDA, approximately one in every 170 Kengreal patients had a serious bleed versus approximately one in every 275 patients taking Plavix.
In a statement, the Medicines Co. said it expects Kengreal to be available in the U.S. by July.